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FDA Requests Testing to Prevent Contamination by Melamine

By Oguz Ozdemir

The U.S. Food and Drug Administration (FDA) issued guidance on August 6, 2009 to advise pharmaceutical companies of the possibility of contamination by melamine while preparing and manufacturing their medical products.

Melamine is an organic base with components similar to cyanide. It is more than half nitrogen and becomes fire retardant when mixed with resins. It has a wide array of uses and has been included in cleaning products, pesticides, and fertilizers. If a certain amount of melamine is ingested it has been known to cause kidney failure and even death. The FDA is requesting that pharmaceutical companies, including manufacturers, suppliers and repackaging companies, test for the possibility of melamine contamination in their products.

There has been no evidence of melamine contamination in the United States as of yet, however the FDA is taking precautionary measures in light of some recent reports that have shown up in products from China. In recent years China has stepped up to be the largest exporter of melamine in the world. The Chinese use the synthetic component in pet foods and baby formula.

A few years ago there was a massive pet food recall after animals who consumed melamine tainted products from China became seriously ill. Many animals died as a result of kidney failure due to the contamination of the pet food. It was also used by the Chinese manufacturers in animal feed.

In September of 2008 melamine was found in milk and infant formulas that were manufactured in China. The contamination led to kidney stones and kidney failure among the children who ingested the products. More than 300,000 people became ill from these products. Almost 13,000 people had to be hospitalized and there were reports of four infant deaths.

The Chinese companies add melamine to milk products because of the high nitrogen content. This procedure masks the true value of the milk products and makes them appear to have a higher protein content than they really have. More than 20 percent of the companies that produce dairy products in China use melamine.

By October of 2008 the FDA initiated methods for testing infant formulas and by December 2008 quicker and less expensive methods were developed to check for melamine in liquids. Since the events that led to the massive pet food and infant formula contaminations, the FDA is committed to preventing similar situations from occurring in the United States.

The FDA has issued a comprehensive guide for everyone involved in producing pharmaceuticals. The guide for Pharmaceutical Components at Risk for Melamine Contamination is available on the FDA website.

If you feel that you may have experienced contamination from exposure to melamine, contact your physician immediately to determine the level of side effects. You may also want to contact the attorneys at Napoli Bern Ripka LLP for a free consultation to determine what course of action you may want to take as a result of any manufacturing negligence.

Our experience legal team has vast knowledge of FDA recalls, defective medical products and other areas where innocent people become victims due to negligence. Give us a call at 1-888-LAW-IN-NY today so that we can provide you with valuable information.

Originally posted at InjuryBoard by Oguz Ozdemir

Full post as published by New York City Personal Injury Lawyer on August 13, 2009 (boomark / email).